New CMC leader — and former colleague — Mike Markey says, “What’s most important to remember about a virtual company is all of our functions work at a desk. None of us actually have hands on; we rely on our CMO partners to get the work done. For me, the external project managers become an integral part of my day-to-day work.”
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.
Although it has remained relatively insulated from broader worldwide economic trends, the biopharmaceutical industry continues to focus on improved bioprocessing technologies to reduce costs and increase efficiencies. Targeting improvements in production can not only lower operational costs, it also can improve weak development pipelines, especially in developing economies.
Part 1 of this two-part Q&A explored the ways in which the FDA encourages innovation, the role of the agency’s Emerging Technology Team (ETT) in manufacturing innovation, and the innovation-safety balance for rare or orphan disease treatments. In this installment, the experts discuss whether compounding pharmacies can help enable iterative development, the feasibility of just-in-time drug manufacturing, and recommendations for speeding materials release.
This paper broadly describes a model-based SDD product development methodology as well as a control strategy that is based upon fundamental understanding of the formulation and the process.
“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.
One way to lower the suspension viscosity of a drug is through the use of highly-concentrated crystalline suspensions, or protein crystals.
Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.
In 2009, Fujifilm Diosynth Biotechnologies (Fujifilm), a biologics CDMO for over 20 years, sought to expand its cell culture operations to meet the industry’s need for more manufacturing capacity. Fujifilm began to look at single-use technology (SUT), and questioned if it offered the same performance as stainless steel when it came to cell growth, cellular productivity, and product quality? By learning the answer to this question and others about SUT, Fujifilm was able to use its knowledge as early adopters, expand its business capabilities, and, as a result, look forward to new growth well into the future.
This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
As the industry — and Merck — sees its pipelines expanding into these more targeted areas of treatment, the call for flexibility and speed gets even louder. Many feel an answer to this is single-use technology (SUT). At Merck, there has been a continued momentum of sales in biologics and vaccines over the last 15 years. However, we had not fully explored SUT or its full potential implementation in our facilities. That is, until an outside industry expert gave us the brutally honest assessment that we were “behind” when it came to SUT.
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Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
Collaboration takes many forms; this article will look at how document production, distribution and archiving are affected by the virtual pharma model and in clinical and manufacturing quality settings.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.